FDA Registration
Active
🇺🇸 United States
LIFEPAK Temperature Adapter Cable
Reg #: 3015876
·
FEI: 3015876
·
Expires 2025
Products
9
Proprietary Names
2
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- PHYSIO-CONTROL, INC.
- Registration Number
- 3015876
- FEI Number
- 3015876
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 11811 WILLOWS RD., N.E.
- City
- Redmond
- State
- WA
- ZIP
- 98052
- Country
- US
Regulatory Submissions
- 510(k) Number
- K142430
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2017-11-13 |
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2017-11-13 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2017-11-13 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2017-11-13 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2017-11-13 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2017-11-13 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | Class 2 | Cardiovascular | No | 2017-11-13 |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | DRO | Class 2 | Cardiovascular | No | 2017-11-13 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2017-11-13 |
Proprietary Names
LIFEPAK Temperature Adapter Cable
LIFEPAK FLEX Battery Charger
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198